Evaluating Neuromodulation Technologies in Early Recovery
| Status: | Completed |
|---|---|
| Conditions: | Anxiety, Depression, Depression, Insomnia Sleep Studies |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/2/2016 |
| Start Date: | December 2013 |
| End Date: | October 2015 |
| Contact: | Kate Reynolds, MSW |
| Email: | kreynolds@bhpalmbeach.com |
| Phone: | 561-465-1263 |
A Comparator Trial Evaluating Three Neuromodulation Technologies' Effectiveness in Early Recovery From Substance Abuse Disorders as Compared to Relaxation Therapy
The study is an open-label comparative effectiveness clinical trial evaluating the impact of
three neuromodulation treatment devices to improve the mental health and sobriety status of
recovering substance abuse patients. We intend to enroll 200 patients to give us a
sufficient number of subjects for the planned comparisons. Following informed consent and
baseline assessment, patients will be randomly assigned to receive either 1) 15 40-minute
sessions of Nexalin Brain Stimulator, a cranial electrical stimulation (CES) device,
once-per-day within a 3-week time-frame; 2) 30 20-minute sessions of the Fischer Wallace
Stimulator, another CES device, twice-per-day within a 3-week time-frame; 3) 15 40-minute
sessions of the DAVID Delight, an audio-visual stimulation device (AVS), once-per-day within
a 3-week time-frame; OR 4) the control-group condition of 15 40-minute relaxation therapy
sessions once-per-day within a 3-week time-frame. All subjects will then be reassessed at
the end of the 3 weeks of treatment and again 1, 3, and 6 months later. In addition to the
assigned treatments, all patients will also receive the standard array of services that are
provided by Behavioral Health of the Palm Beaches (BHOPB) including as clinically
appropriate, psychiatric medication management and Eye Movement Desensitization Response
(EMDR) therapy. Patients diagnosed with Post Traumatic Stress Disorder (PTSD) are assessed
to determine their suitability for EMDR and if suitable, will receive 2 or more EMDR
sessions. Patients without PTSD do not receive EMDR therapy.
three neuromodulation treatment devices to improve the mental health and sobriety status of
recovering substance abuse patients. We intend to enroll 200 patients to give us a
sufficient number of subjects for the planned comparisons. Following informed consent and
baseline assessment, patients will be randomly assigned to receive either 1) 15 40-minute
sessions of Nexalin Brain Stimulator, a cranial electrical stimulation (CES) device,
once-per-day within a 3-week time-frame; 2) 30 20-minute sessions of the Fischer Wallace
Stimulator, another CES device, twice-per-day within a 3-week time-frame; 3) 15 40-minute
sessions of the DAVID Delight, an audio-visual stimulation device (AVS), once-per-day within
a 3-week time-frame; OR 4) the control-group condition of 15 40-minute relaxation therapy
sessions once-per-day within a 3-week time-frame. All subjects will then be reassessed at
the end of the 3 weeks of treatment and again 1, 3, and 6 months later. In addition to the
assigned treatments, all patients will also receive the standard array of services that are
provided by Behavioral Health of the Palm Beaches (BHOPB) including as clinically
appropriate, psychiatric medication management and Eye Movement Desensitization Response
(EMDR) therapy. Patients diagnosed with Post Traumatic Stress Disorder (PTSD) are assessed
to determine their suitability for EMDR and if suitable, will receive 2 or more EMDR
sessions. Patients without PTSD do not receive EMDR therapy.
Inclusion Criteria:
Adults between the ages of 18 and 75 in early recovery from a substance abuse disorder.
Exclusion Criteria:
The exclusion criteria are patients diagnosed with 1) an uncontrolled seizure disorder, 2)
a psychotic disorder with currently active features (e.g., paranoia), 3) a dissociative
identity disorder, 4) a manic episode within the past month, 5) patients with a pace-maker
or implanted vagal nerve stimulator, patients prescribed Subocone, Subutext, &/or any
psychostimulant medication (e.g., Alderol, Concerta, Focalin, Metadate, Vyvance, etc.)
since these medications interfere with the ability of these neuromodulation devices'
ability to have the intended effect on patients, and 7) pregnant woman.
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